A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's

Study Identifier:

417-201-00042

ClinicalTrials.gov Identifier:

NCT06928142

EudraCT Identifier:

N/A

Sponsor:

Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Contact Information:

844-687-8522 or [email protected]

Will Be Recruiting

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Study Details

Medical Condition

Autoimmune

Study Drug

Biological: Sibeprenlimab

Date

Apr 2025 - Mar 2027

Phase 1/2

Phase 2/3

Phase 1

Phase 2

Phase 3

Phase 4

N/A

Patient Requirements

Sex: Female & Male

Age: 18 - 75 Years

Requirements Information

Protocol Summary

This is a phase 2 study to evaluate the effects of sibeprenlimab 400 mg administered subcutaneously (SC) every 4 (Q4) weeks as an add-on to background treatment in participants with Sjögren's disease.

Study Locations

Location

Status

Location

Medvin Clinical Research - Riverside

Riverside, California, United States, 92508

Status

N/A

Location

Medvin Clinical Research - Tujunga

Tujunga, California, United States, 91042-2706

Status

N/A

Location

Bay Area Arthritis and Osteoporosis

Brandon, Florida, United States, 33511-4885

Status

N/A

Location

Clinical Research of West Florida Inc

Clearwater, Florida, United States, 33765

Status

N/A

Location

GNP Research - Florida

Fort Lauderdale, Florida, United States, 33309

Status

N/A

Location

Vantage Clinical Trials - Tampa - ClinEdge - PPDS

Tampa, Florida, United States, 33614

Status

N/A